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Great insight and I would agree with you but you cannot make someone settle. Hikma and Dr. Reddy's may just want to go all the way to trial. We cannot assume they will approach this rationally and see they have limited upside.
That is the dilemma here: Hikma and Dr. Reddy's may just decide not to settle. In that case where does that leave us?
Reverse: 50%
Affirm: 50%
Very interesting. Thanks!
What makes you so confident generics would want to settle before oral arguments?
What should JT do? Great question and there are no easy answers at this point. This is where JT & Singer need to earn their millions of dollars in compensation.
The simple answer is well just go through with the appeal. But what if you lose? What contingencies are in place.... Will the other non-contested patents in the Orange Book truly prevent generics from entering. If so, Wall Street has not picked up on this.
Is a settlement still possible with a vacatur. Will some sort of agreement be reached on the doorsteps of the court room.
Any BO now would be significantly discounted given the uncertainty with the appeal. Sure there are ways it could be structured to take into account the appeal with a CVR but to date there has been no BO so what does that tell you. Likely significant valuation gap between what AMRN management believes it is worth and what a willing buyer is willing to pay.
What is clear to me is that the generics are crafty and are trying to do all they can to add to the confusion with their brief. The fish oil line as previously cited is just one example. This will still come down to the judges and that carries risk. We are praying to have a judge on the panel named Newman who is in her 90s. Let that sink in. If we don't get Newman will the other judges be paying close enough attention to grasp everything at stake.
We are within 10 days of our reply being filed by Singer and then oral arguments should be scheduled. There is a lot hanging in balance here including Europe.
JT mentioned holistic several times on the last call but only he knows truly what his ultimate play is here. It has been mentioned he is risk averse but going to trial again seems to run counter to that. Where are the Baker Brothers in all of this? Do you think JT keeps his job if AMRN loses the appeal? Does this factor into his decision.
This is game theory at its finest. The fortunate thing for us is the calendar will force a decision soon. Stay tuned.
Generics broad-based labeling of fish oil is a deliberate attempt to influence the judges. Hopefully Amarin and Singer have an answer for this. Generics are very crafty and cunning with their approach. It certainly worked in the first trial as Judge Du bought the argument and the rest was history.
Look at how the generics used the Mori, Hayashi, and the other trials even though they were the wrong population. It was a classic straw man argument to take the focus away from the two distinct populations (less than 500 and greater than 500) and it worked.
In their brief the generics mention that secondary considerations were discussed for 18 pages out of the 70 in Judge Du's opinion--to influence the Judges into thinking that Judge Du thoroughly considered the secondary considerations before deciding they were not enough to rebut the prima facie case of obviousness. Again they are crafty.
Generics even state that Judge Du did not weigh the secondary considerations against each other but rather Amarin took the statement out of context. see page 31
Page 22 Most of Amarin’s secondary considerations evidence focused on its REDUCE-IT study—and the court found that REDUCE-IT lacks a nexus to the asserted claims.
Again trying to get the appellate court to disregard the secondary considerations because of a lack of a connection.
Page 46 – In short, Amarin told FDA and its investors the precise opposite of what it is now arguing to this Court.
Trying to use Amarin's own internal documents and submissions to the FDA against Amarin.
This is who we are dealing with.
This is why in my opinion it will all come down to the judges because there is no certainty they are awake and paying attention. Is John Thero willing to go all the way with the trial and roll the dice again? The clock is ticking.
Thanks. Now we just need the right judges.
Look who presided over this case: "Before NEWMAN, O'MALLEY, and REYNA..."
This is all about the judges. If we get the same panel we should be golden. We need Newman.
Great post marjac!
JL--thanks for these posts. Very interesting observations.
Why do you think AMRN management is not communicating this to Wall Street in terms of getting out in front with this story and considering the share price decimation and explaining that there is still much value here despite the Marine patent loss?
Is "what is coming by the end of summer" related to AMRN or the broader market / economy?
Excellent point. Singer can only do so much. Judges are key. Hope Amarin management truly understands this risk with the appeal.
She had her mind made up and ruled accordingly. Judges are human. This is the risk with going to trial. Encountering a judge such as her.
Why do you think the generics' brief will be weak?
I know the law thank you. LOL. I also live in the real world. Judges are key.
Singer will get it in. He is skilled enough to do so. That's why he earns the money he does.
Him getting it in though is separate from whether it will be enough to reverse this for Amarin? That will largely fall on which judges we get. The judges will be the determinant here and that is something Amarin cannot control. This is bet the company litigation and Amarin is in the thick of it.
Excellent points marjac. Even with Friday's published paper, this appeal is still a toss up due to the erratic Federal Circuit (judges).
EXCELLENT POST! You nailed it with this one.
I hope you are correct.
What is giving you this confidence without knowing which judges we will get?
Correct. I asked my friend who is a patent attorney and who knows Singer about what you are alluding to. And my friend has argued before the appellate court.
His response:
"These are tough questions. The problem with the anti-patent judges is that many of them don’t understand patent law or technology. These highly technical arguments will probably be lost on them anyway, so you’re correct the anti-patent judges are the real danger here."
This was her first patent case. Judges are human. They are not infallible.
JL I agree with you. She had her mind made up and crafted her ruling to fit her beliefs. It is shameful.
She invalidated all of the patents in dispute. Incredulous.
Interesting seems he would be more motivated for the change of control (sale) than getting removed by the BOD or a large shareholder in the event litigation is botched a second time around. Seems like he gets 100% acceleration of vesting if there is a change of control. From the proxy:
John F. Thero
In the event that Mr. Thero’s employment is terminated by the Company without cause or he resigns for good reason, he will be entitled to severance as follows: continuation of base salary for twelve (12) months; continuation of group health plan benefits for up to twelve (12) months to the extent authorized by and consistent with 29 U.S.C. § 1161 et seq. (commonly known as “COBRA”) with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Thero as in effect on the date of termination; and twelve (12) months of accelerated vesting of all outstanding equity incentive awards to the extent subject to time-based vesting. In lieu of the foregoing, if Mr. Thero’s employment is terminated by the Company without cause or he resigns for good reason, in either case, within twenty-four (24) months following a change of control, he will be entitled to severance as follows: continuation of base salary for eighteen (18) months; continuation of group health plan benefits for up to eighteen (18) months to the extent authorized by and consistent with COBRA with the cost of the regular premium for such benefits shared in the same relative proportion by the Company and Mr. Thero as in effect on the date of termination; a lump sum cash payment equal to the full target annual performance bonus for the year during which the termination occurred; and 100% acceleration of vesting of all outstanding equity incentive awards. Receipt of the severance payments and benefits is subject to the execution and effectiveness of a separation agreement in a form acceptable to the Company which shall include a release of claims against the Company and related persons and entities.
When do you think such sale would occur? Before oral argument? Post oral argument but before court issues its decision?
She had a leaning and thought she knew best (above the USPTO) and ruled as such. This is the risk you take with litigation. There are no certainties. Dealing with humans in black robes.
Trust me, I realize it is too late for settlement. But it may not be too late for a buyout or "holistic value" creation for shareholders.
There are no certainties with this upcoming litigation. We have to face the reality: judges control our fate.
It is what it is.
This is truly bet the company litigation.
It would be one thing for JT and the BOD to be surprised by litigation risk the first time. A second time around would no longer be a surprise. How will JT and the BOD handle / mitigate this risk? Or are they so confident they are willing to roll the dice again.
It will all come down to the judges. Is JT and team willing to take this risk?
Game theory at its finest.
We shall see if he earns his compensation package with his next move.
Add to the list a so-called conservative CEO who looks like is willing to roll the dice again on litigation a second time around. What gives...
Right. Something does not reconcile: a so-called "conservative CEO" wanting to roll the dice again on litigation that the Company could very well win but it all comes down to the judges. JT is not dumb and surely he realizes this so what is his plan here......? We all know by now litigation is risky. You can have the best brief, lawyer, and still end up losing. If they go this route again, what else are they banking on to mitigate things.....
This is even more pronounced when you only have one drug: it truly is bet the company litigation. Go figure. A conservative CEO and bet the company litigation....hmmm
Studies of other cardiovascular drugs include Amarin Corp. ’s plans to test whether its fish oil-derived drug, Vascepa, can prevent or treat Covid-19 infection and reduce the risk of cardiovascular problems in patients who sustained heart damage during their illness. It also wants to test whether the drug, first approved in 2012 to treat adults with very high levels of triglycerides, has antiviral effects.
Amarin says Vascepa may help prevent or treat inflammation caused when the SARS-CoV-2 virus attacks the endothelium, the layer of cells lining blood vessels and the inner walls of the heart chambers. Vascepa is a high-purity prescription form of eicosapentaenoic acid, or EPA, which has been shown to reduce a marker of inflammation, C-reactive protein.
“It quiets down inflammation,” said Deepak Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and an investigator in a pilot study Amarin announced recently to test Vascepa as a treatment on hospitalized Covid-19 patients at the University of Toronto.
Amarin is planning studies elsewhere on health-care workers, people with underlying cardiovascular issues and other types of patients.
Statins, the cholesterol-lowering drugs taken by millions of Americans, have also shown promise as protective agents against serious Covid-19 complications.
Two large studies across several continents have suggested individuals with heart disease who were already taking statins were more likely to survive Covid-19 than those who weren’t taking the medicines, though the drugs’ potential effect hasn’t been directly tested yet.
In a 154-person analysis by researchers in Belgium, elderly patients taking statins were three times as likely to be free of Covid-19 symptoms. The observational study, published last month on a so-called preprint server, hasn’t been peer-reviewed.
Some trials are also studying the effect on Covid-19 patients of antiplatelet drugs, which prevent the formation of blood clots by keeping blood platelets from staying together, and of blood thinners, which are now routinely given at therapeutic doses to Covid-19 patients to prevent blood clots.
New York University’s Langone Hospital aims to enroll 1,000 patients to assess whether blood thinners are more effective at preventing blood clots or death when given at high doses rather than low doses. While doctors accept that low-dose blood thinners help Covid-19 patients, it isn’t clear whether high doses might be more effective, said Jeffrey Berger, director of the Center for the Prevention of Cardiovascular Disease at New York University Grossman School of Medicine.
Dr. Berger also cited the high frequency of Covid-19 patients who have developed blood clots in areas like the leg and the lungs, including patients who don’t have underlying heart disease or other risk factors.
“While it is less common, it is not infrequent,” he said. “That is what is so concerning with this disease.”
WSJ Article mentions AMRN
Heart Drugs Show Promise with COVID-19 Complications
https://www.wsj.com/articles/heart-drugs-show-promise-with-covid-19-complications-11591102632?mod=hp_lead_pos7
Thanks Raf. I'm responding to a few messages here.
I think this video is a must watch for all investors.
Essentially this legal analyst's view is it's a coin flip in terms of our chances of winning. It all comes down to this.
JL's analogy of the titanic was great. This is game theory at its finest. Perhaps AMRN wants to see the draw of the judges the day of the oral argument. That day will be the tell all for sure.
Triple 88--I believe we are past the point of settlement. If settlement was going to happen it should have occurred pre this bad judgement. Can't go back now. Have to deal with the reality we face.
Will come down to the judges we draw. Let's hope they are paying attention this time.
It's always a risk and that is what hangs in balance here: which judges will preside over the case. The judges control everything here and that is the risk that JT and team have to game plan for and try to contend with. This is what trials / litigation entail. Uncertainty looms. We get the right judges we are golden. We get the wrong judges...we are not. Singer did a great job but judges still control our fate.
How are JT, Singer and team prepping for this. Will be interesting to see. It is the ultimate question that won't be resolved until the day of oral argument. Singer knows this. Question is are JT, team, and the Board comfortable with such risk....the valuation of the company is hanging on this.
Interesting. I guess that would be one way to get everyone's attention on the travesty that just happened: hey the US judicial system (one lone judge) invalidated our IP that we took years developing so we sold the Company to a Chinese entity.
Talk about the irony.
Agree 100%.
My friend who is a patent attorney was shocked this case was in Nevada. That is the first thing he commented on.
The Eastern District of Texas was also a preferred forum for patent owners. https://www.bloomberg.com/opinion/articles/2017-05-25/the-texas-town-that-patent-trolls-built-j34rlmjc Plaintiffs did well there.
Have no idea why we chose or ended up in the 9th circuit. SMH
LOL. Briefs will not carry the day. LOL
Do not make this mistake again. It is all about the judges.
Wrong judges....bad outcome. Don't get caught up in the legal minutiae of the briefs.
A good lawyer knows the law, a great lawyer knows the judge.
Right but you are assuming this person wouldn't send a brown envelope with materials or info to the court regarding this case.
MRC has shown a willingness in the past to send a lot of correspondence in to the FDA. Why was MRC so interested in this outcome? Why didn't MRC stop after the ADCOM or FDA approval?
Relentless...
I listened. We know MRC was corresponding with the FDA. Do we really think MRC didn't send anything into Judge Du's office or her clerk?
Who knows? But MRC has shown that it was relentless in the past.
All very interesting. I wonder if JT and the Board of Directors realize this.
He always said he will do what is best for shareholders to maximize shareholder value.